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Evaluation of a Treat and Extend Regimen of Intravitreal Aflibercept for Macular Edema Secondary to CRVO (CENTERA)

Primary Purpose

Central Retinal Vein Occlusion

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Aflibercept (Eylea, BAY86-5321)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Retinal Vein Occlusion focused on measuring Bayer, Aflibercept, Eylea, Intravitreal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Center-involved macular edema secondary to CRVO for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of ≤ 3 months since onset of macular edema at their scheduled baseline visit).
  • Adult subjects diagnosed with macular edema secondary to CRVO who are scheduled to be treated with IVT aflibercept as per investigator's routine treatment practice with the intent to use a T&E regimen after initial dosing.
  • Treatment-naïve subjects for macular edema secondary to CRVO.
  • Men and women ≥ 18 years of age.
  • Documented BCVA of ETDRS letter score of 73 to 24 letters (Snellen equivalent of 20/40 to 20/320) in the study eye.

Exclusion Criteria:

  • Previous PRP or macular laser photocoagulation in the study eye.
  • Any prior or concomitant ocular treatment (e.g. anti-VEGF therapy, corticosteroids) in the study eye for macular edema secondary to RVO, except dietary supplements or vitamins prior to inclusion in the study. Intraocular anti-VEGF treatment is permitted for the treatment of diseases of fellow eye except for those that are specifically excluded.
  • Prior systemic anti-VEGF or corticosteroid therapy, investigational or approved, within the last 3 months before the first dose in the study.
  • Previous use of intraocular corticosteroids in the study eye at any time or use of periocular corticosteroids in the study eye within 12 months prior to Day 1.
  • Any active intraocular, extraocular, and periocular inflammation or infection in either eye within 4 weeks of screening.
  • Any history of allergy to povidone iodine.
  • Known serious allergy to the fluorescein sodium for injection in angiography.
  • Presence of any contraindications indicated in the EU commission/locally approved label for IVT aflibercept: hypersensitivity to the active substance IVT aflibercept or to any of the excipients; active or suspected ocular or periocular infection; active severe intraocular inflammation.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intravitreal (IVT) aflibercept

Arm Description

Participants with macular edema secondary to CRVO were treated with the study drug intravitreal aflibercept

Outcomes

Primary Outcome Measures

The Proportion of Participants Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline
Participants who completed the study with a gain of ≥ 15 letters or dropped the study after Week 24 and having a permanent resolution of macular edema and a gain of ≥ 15 letters from baseline with regard to the latest BCVA assessment. The ETDRS chart includes 70 letters in total, more letters read correctly represents a better visual acuity.
The Proportion of Participants With a Mean Treatment Interval Between Injections of ≥ 8 Weeks
Participants who completed the study with a mean treatment interval between injections of ≥ 8 weeks or dropped out of the study after Week 24 and having a permanent resolution of macular edema

Secondary Outcome Measures

The Mean Treatment Interval Between Injections
The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline
The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity
The Change in Central Retinal Thickness (CRT) From Baseline
CRT was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).
The Number of Injections Per Participant
The Proportion of Participants Who Gain ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline
The ETDRS chart includes 70 letters in total. More letters read correctly represents a better visual acuity
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
The change in retinal non-perfusion status by fundus angiography (FA)/fundus photography (FP)-confirmed ischemic disc area. The status was categorized into: no non-perfusion, <10 ischemic disc area, >=10 ischemic disc area and missing status
The Proportion of Participants With Absence of Subretinal Fluid
Incidence and Severity of Ocular Treatment-emergent Adverse Events

Full Information

First Posted
June 10, 2016
Last Updated
June 19, 2020
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02800642
Brief Title
Evaluation of a Treat and Extend Regimen of Intravitreal Aflibercept for Macular Edema Secondary to CRVO
Acronym
CENTERA
Official Title
A Multi-center, Single-arm, Interventional Phase 4 Study to Evaluate a Treat and Extend Regimen of Intravitreal Aflibercept for Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 10, 2016 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Central retinal vein occlusion (CRVO) occurs when the main blood vessel that transports blood away from the retina (the very back portion of the eye) becomes blocked, causing the leakage of fluid into the retina and thereby causing a swelling of the macula (the portion of the retina responsible for fine vision). This swelling is called macular edema. When the macula swells with fluid, central vision becomes blurry. The study drug aflibercept has been shown to reduce the amount of fluid and blood leaked into the retina. It can help to stabilize, and in many cases, improve the vision loss related to CRVO. Aflibercept has been approved for the treatment of macular edema secondary to CRVO in the United States (US), European Union (EU), Japan, and other countries. The study was considered research because, although the study drug was already on the market for macular edema secondary to CRVO, there were no studies available that addressed the questions of what were useful intervals for treating and assessing patients, how did they differ among patients, and how were criteria applied for retreatment. The purpose of this study was to evaluate the effectiveness, treatment interval, and safety of the treatment regimen (pattern for administering treatment) in subjects with macular edema secondary to CRVO. In addition, this study explored new imaging methods for assessing the affected eye.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Retinal Vein Occlusion
Keywords
Bayer, Aflibercept, Eylea, Intravitreal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravitreal (IVT) aflibercept
Arm Type
Experimental
Arm Description
Participants with macular edema secondary to CRVO were treated with the study drug intravitreal aflibercept
Intervention Type
Drug
Intervention Name(s)
Aflibercept (Eylea, BAY86-5321)
Intervention Description
The recommended dose for intravitreal aflibercept was 2 mg equivalent to 50 μL. Study treatment was administered at baseline and at monthly intervals until stabilization of disease. When stability was achieved, the treatment interval could be extended based on visual and anatomic outcomes as judged by the treating investigator.
Primary Outcome Measure Information:
Title
The Proportion of Participants Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline
Description
Participants who completed the study with a gain of ≥ 15 letters or dropped the study after Week 24 and having a permanent resolution of macular edema and a gain of ≥ 15 letters from baseline with regard to the latest BCVA assessment. The ETDRS chart includes 70 letters in total, more letters read correctly represents a better visual acuity.
Time Frame
Baseline, Week 24 and Week 76
Title
The Proportion of Participants With a Mean Treatment Interval Between Injections of ≥ 8 Weeks
Description
Participants who completed the study with a mean treatment interval between injections of ≥ 8 weeks or dropped out of the study after Week 24 and having a permanent resolution of macular edema
Time Frame
From the last actual visit of the initiation phase to Week 76
Secondary Outcome Measure Information:
Title
The Mean Treatment Interval Between Injections
Time Frame
From baseline to Week 76
Title
The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline
Description
The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity
Time Frame
Baseline and Week 24, 52, and 76
Title
The Change in Central Retinal Thickness (CRT) From Baseline
Description
CRT was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).
Time Frame
Baseline and Week 24, 52 and 76
Title
The Number of Injections Per Participant
Time Frame
From baseline to Week 76
Title
The Proportion of Participants Who Gain ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline
Description
The ETDRS chart includes 70 letters in total. More letters read correctly represents a better visual acuity
Time Frame
Baseline and Week 24, Week 52
Title
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Description
The change in retinal non-perfusion status by fundus angiography (FA)/fundus photography (FP)-confirmed ischemic disc area. The status was categorized into: no non-perfusion, <10 ischemic disc area, >=10 ischemic disc area and missing status
Time Frame
Baseline and Week 24, 52 and 76
Title
The Proportion of Participants With Absence of Subretinal Fluid
Time Frame
Baseline, week 24, week 52 and week 76
Title
Incidence and Severity of Ocular Treatment-emergent Adverse Events
Time Frame
Up to 30 days after week 76

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Center-involved macular edema secondary to CRVO for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of ≤ 3 months since onset of macular edema at their scheduled baseline visit). Adult subjects diagnosed with macular edema secondary to CRVO who are scheduled to be treated with IVT aflibercept as per investigator's routine treatment practice with the intent to use a T&E regimen after initial dosing. Treatment-naïve subjects for macular edema secondary to CRVO. Men and women ≥ 18 years of age. Documented BCVA of ETDRS letter score of 73 to 24 letters (Snellen equivalent of 20/40 to 20/320) in the study eye. Exclusion Criteria: Previous PRP or macular laser photocoagulation in the study eye. Any prior or concomitant ocular treatment (e.g. anti-VEGF therapy, corticosteroids) in the study eye for macular edema secondary to RVO, except dietary supplements or vitamins prior to inclusion in the study. Intraocular anti-VEGF treatment is permitted for the treatment of diseases of fellow eye except for those that are specifically excluded. Prior systemic anti-VEGF or corticosteroid therapy, investigational or approved, within the last 3 months before the first dose in the study. Previous use of intraocular corticosteroids in the study eye at any time or use of periocular corticosteroids in the study eye within 12 months prior to Day 1. Any active intraocular, extraocular, and periocular inflammation or infection in either eye within 4 weeks of screening. Any history of allergy to povidone iodine. Known serious allergy to the fluorescein sodium for injection in angiography. Presence of any contraindications indicated in the EU commission/locally approved label for IVT aflibercept: hypersensitivity to the active substance IVT aflibercept or to any of the excipients; active or suspected ocular or periocular infection; active severe intraocular inflammation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
City
Parramatta
ZIP/Postal Code
2150
Country
Australia
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2H 0C8
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8G 5E4
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
City
Boisbriand
State/Province
Quebec
ZIP/Postal Code
J7H 1S6
Country
Canada
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 2V4
Country
Canada
City
Quebec
ZIP/Postal Code
G1V 1T6
Country
Canada
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
City
Bordeaux
ZIP/Postal Code
33076
Country
France
City
Dijon Cedex
ZIP/Postal Code
BP 1542-21
Country
France
City
Lyon
ZIP/Postal Code
69004
Country
France
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
City
Karlsruhe
State/Province
Baden-Württemberg
ZIP/Postal Code
76133
Country
Germany
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86156
Country
Germany
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
City
Hannover
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
30625
Country
Germany
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50935
Country
Germany
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00198
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20157
Country
Italy
City
Ancona
State/Province
Marche
ZIP/Postal Code
60126
Country
Italy
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33012
Country
Spain
City
Sant Cugat del Vallés
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
City
Viladecans
State/Province
Barcelona
ZIP/Postal Code
08840
Country
Spain
City
Barcelona
ZIP/Postal Code
08024
Country
Spain
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
City
Sunderland
State/Province
Tyne And Wear
ZIP/Postal Code
SR2 9HP
Country
United Kingdom
City
Bradford
State/Province
West Yorkshire
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
City
Bristol
ZIP/Postal Code
BS1 2LX
Country
United Kingdom
City
Colchester
ZIP/Postal Code
CO3 3NB
Country
United Kingdom
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33556381
Citation
Korobelnik JF, Larsen M, Eter N, Bailey C, Wolf S, Schmelter T, Allmeier H, Chaudhary V. Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend for Macular Edema in Central Retinal Vein Occlusion: the CENTERA Study. Am J Ophthalmol. 2021 Jul;227:106-115. doi: 10.1016/j.ajo.2021.01.027. Epub 2021 Feb 6.
Results Reference
derived
Links:
URL
http://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products.
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

Evaluation of a Treat and Extend Regimen of Intravitreal Aflibercept for Macular Edema Secondary to CRVO

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